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Chemical Biological Defense Acquisition Initiatives Forum

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Upcoming Events. Joint Program Executive Office for Chemical and Biological Defense ... Guardian Information to Improve the SOW for any Upcoming Procurements ... – PowerPoint PPT presentation

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Title: Chemical Biological Defense Acquisition Initiatives Forum


1
Chemical Biological Defense Acquisition
Initiatives Forum
UNCLASSIFIED
  • December 15, 2006

STEPHEN V. REEVES Major General, USA Joint
Program Executive Officer for Chemical and
Biological Defense(703) 681-9600
Distribution Statement A Approved for Public
Release
2
Updates
  • Congressional Outlook FY08 Budget
  • Lean Six Sigma
  • EVMS Policy
  • BARDA
  • Industry Security Clearances
  • Biosurety Regulations
  • Experimentation in Requirements Definition
  • Contracting Opportunities
  • Upcoming Events

3
Congressional Outlook
  • FY 08 Presidents Budget Submission
  • Budget Drivers
  • War Costs / OM Bills
  • Supplementals
  • Tri-Care for Life
  • Congressional Budget Adds to CBDP
  • FY03 400M FY07 44M

4
Lean Six Sigma
  • Key Element of DoD Business Transformation
  • Applies Quantitative Methods to Process
    Improvement
  • Lean Six Sigma Technique Deployed Through-out
    Services

5
Earned Value Management Thresholds
  • DoD Revised Earned Value Management System (EVMS)
    Contract Thresholds in March 2005
  • A Validated EVMS is Required for Contracts Over
    50M
  • A Tailored EVMS is Required for Contracts From
    20M - 50M
  • EVMS is Optional for Contracts Less Than 20M
    Project Manager Decides Based on Business Case
    Analysis
  • EVMS is Based on Industry Standard ANSI/EIA 748
  • Work Breakdown Structure, Contract Performance
    Reporting and Integrated Master Schedule Also
    Required with EVMS

References OSD EVM Web Site http//www.acq.osd.m
il/pm/ EVM Community of Practice
https//acc.dau.mil/evm
6
Biomedical Advanced Research and Development
Authority (BARDA)
  • Biodefense and Pandemic Vaccine and Drug
    Development Act of 2006 (HR 5533)
  • Establishes the Biomedical Advanced Research and
    Development Authority (BARDA) within DHHS
  • Designates BARDA as the Single Federal Authority
    with the Core Mission of Heading Off a Public
    Health Catastrophe (Epidemic, Pandemic or
    Bioterrorism) Through Coordinated Research and
    Development Activities for Countermeasures to
    Bioterrorism and Pandemic Influenza
  • Authorizes One or More Federally-funded Research
    and Development Centers, or University-Affiliated
    Research Centers
  • Status Pending Joint House and Senate Conference

7
BARDA and BioShield
  • BARDA
  • BARDA Focuses Solely to Promote Advanced Research
    Development of Bioterrorism/ Pandemic
    Countermeasures
  • BARDA Overseen by DHHS
  • BioShield
  • H.R. 5533 Clarifies Project BioShield as a
    Program that Provides Incentives to Companies to
    Manufacture Vaccines and Drugs
  • BioShield Covers Certain Products (e.g.,
    qualified and security countermeasures) that
    Address Public Health Threats Caused by Acts of
    Terrorism.
  • Project BioShield Expedites National Institutes
    of Health (NIH) RD Efforts
  • Allows FDA to Make Countermeasures Available
    During an Emergency
  • Allows the Federal Government to Procure and
    Maintain Medical Countermeasure Supplies (DHS,
    5.6B over 10 yrs)
  • Overseen by DHS and DHHS

8
CBDP and BARDA
  • BARDA Provides an Opportunity to Leverage and
    Synchronize Medical Countermeasure Investments
  • CBDP Should Coordinate with DHHS in the
    Development of the DHHS Strategic Plan for
    Consideration of DoD Opportunity Savings and
    Synchronization
  • BARDA May Be Used to Leverage TMTI Countermeasure
    Investments, Especially FDA Approaches

9
GAO Report on Security Clearances
  • Industry Personnel Hold 34 of 2.5 Million DoD
    Clearances
  • Office of Personnel Management Investigates
  • GAO Found for Top Secret Clearances
  • 446 Days Required for Initial Clearance
  • 545 Days Required for Clearance Update
  • GAO Recommended
  • More Accurate Measurement of Process Time
  • Use of Information Technology Solutions
  • Update the Plan to Improve the Process
  • Metrics to Monitor Effectiveness of New Procedures

10
Speeding Clearances - Reducing Backlog
  • All Investigations Placed Under OPM
  • OPM Added More Investigators
  • Closer OPM Coordination with Records Agencies
  • Resumed Industry Submissions July 2006
  • DoD Increasing Electronic Submissions (eQIP)
  • Additional DoD Positions Added to Reduce
    Adjudication Time
  • Additional Defense Security Service Funding

11
Biosurety Regulations Update
  • DoD Directive 5210.88 Safeguarding Biological
    Select Agents and Toxins. February 2004
  • DoD Instruction 5210.89 Minimum Security
    Standards for Safeguarding Biological Select
    agent and Toxins. April 2006
  • Army Regulation 190-17, Biological Select Agents
    and Toxins Security Program. October 2006
  • Draft Army Regulation 50-X Biological Surety.
    Coordinating with OSD to Minimize Disparities
    with DoD Directive. (Pending Legal Review)

Guidance and Information for Industry at
http//www.dss.mil/index.htm
12
Using Experimentation to Define
Requirements/Concepts of Use
13
Joint CBRN Dismountable Reconnaissance System
Limited Objective Experiment (JCDRS LOE) Phase
III Modular Concept
  • Definition
  • Employment of Mature, Enabling Technologies
    (Plug-n-Play, Interface Standards, Wireless, GPS,
    ) to Provide Net-centric and Modular Capability
  • Integrated Components Designed for Mounted and
    Dismounted Operation
  • Standardization of Data Formats, Communications
    Protocols, and Sensor/Hardware Packaging
  • Benefits
  • Easier CBRN Integration into Platforms
  • Tailorable CBRN Defense Capability
  • Increased Standardization of CBRN Equipment
  • Easily Upgraded Systems
  • Net-Centric Architecture Easily Accessed Data,
    Shared Awareness, Increased Speed of Command, and
    Remote Access to Systems

14
Net-Centric
JCID On A Chip
15
Near Term Industry JPEO Opportunities
16
Near Term Industry JPEO Opportunities (Contd)
Near Term Industry JPEO Opportunities (Contd)
17
JPEO Medical Program Business Opportunities
18
Chemical Biological Information Systems Conference
  • When January 8 11, 2007
  • Where Austin, TX, Renaissance Austin Hotel

19
Advanced Planning Briefing for Industry
  • When April 4 5, 2007
  • Where Washington DC Convention Center
  • Format
  • Day 1
  • JPM/CAPO Joint Brief
  • Day 2
  • JPM/ CAPO 1 on 1 with Industry

20
(No Transcript)
21
BACKUPS
22
Earned Value Management Requirements
  • Cost or Incentive Type Contract Greater Than 50M
  • Compliance with Industry EVM Standard - ANSI/EIA
    748
  • Formal EVMS Validation by DCMA
  • Cost Performance Report
  • Integrated Master Schedule
  • Integrated Baseline Review
  • Ongoing Surveillance by DCMA
  • Cost or Incentive Type Contract Greater Than 20M
    and Less Than 50M
  • Compliance with Industry EVM Standard
  • No Formal EVMS Validation
  • Cost Performance Report
  • Tailored Integrated Master Schedule
  • Integrated Baseline Review
  • Ongoing Surveillance by DCMA

23
Earned Value Management Requirements (Contd)
  • Cost or Incentive Type Contract Less Than 20M
  • EVMS is Optional
  • Business Case Required to Justify EVM

Applying EVM to FFP Contracts is Strongly
Discouraged
24
Biomedical Advanced Research and Development
Authority (BARDA)
  • Through BARDA, DHHS will Coordinate and Oversee
    the Acceleration of Medical Countermeasure and
    Advanced Research and Development by
  • Facilitating Collaboration Among DHHS, Other
    Federal Agencies, Relevant Industries, and
    Academia
  • Facilitating Contacts and Coordinating Efforts to
    Improve Process and Requirements Under the
    Federal Food, Drug, and Cosmetic Act
  • Promoting Innovation to Reduce the Time and Cost
    of Countermeasure and Product Advanced Research
    and Development

25
Biomedical Advanced Research and Development
Authority (BARDA)
  • Rationale
  • The Lack of Commercial Demand for Certain Medical
    Countermeasures has Discouraged Development and
    Created a Funding Gap Between Early Research and
    Transition Investment to Licensure
  • BARDA Intends to Bridge That Gap By
  • Providing Interim Funding at Key Development
    Milestones
  • Offer Grants, Awards Through Other Transaction
    Authority, and Prizes to Industry to Provide
    Incentives to Develop Certain Countermeasures
    Deemed Priorities
  • Encourage Companies to Pursue Medicines Showing
    Promise in Early Research

26
Biomedical Advanced Research and Development
Authority (BARDA)
  • BARDA Requires DHHS to
  • Develop a Strategic Plan to Identify Biological
    and Infectious Disease Threats
  • Evaluate Research and Development Opportunities
  • Conduct Annual Outreach and Working Groups
  • Funding
  • Authorizes the appropriation of 160 million for
    each of fiscal years 2007 and 2008 for activities
    related to the operation of BARDA.
  • The bill also would authorize the appropriation
    of 1 million for each of fiscal years 2007 and
    2008 for the National Biodefense Science Board.
  • Congressional Budget Office (CBO) estimates that
    1 million a year would be necessary for FDA to
    implement activities outlined in the bill.
  • Assuming appropriation of the authorized and
    necessary amounts, CBO estimates that
    implementing H.R. 5533 would cost 33 million in
    2007 and 319 million over the 2007-2011 period.

27
Installation Protection Program (IPP)
  • Industry is Invited to Comment on a Draft IPP
    Statement of Work (SOW)
  • This Provides JPM Guardian Information to Improve
    the SOW for any Upcoming Procurements
  • The SOW is Available at

http//www.jpeocbd.osd.mil
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